Jane Rubinstein

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A social communication intervention in preschool children with autism, although improving parent-child interaction, does not deliver clinically significant benefit in the actual symptoms of autism. This is the conclusion of an Article published in the Lancet, written by Professor Jonathan Green, University of Manchester, UK and colleagues from the Preschool Autism Communication Trial (PACT) Consortium.

Autism is a severe developmental syndrome affecting about 1% of children and resulting in an annual UK cost in childhood of £2.7 billion – higher than asthma or diabetes. Effective early intervention is an international health priority PACT is important as it is by some way the largest autism treatment trial of its type yet undertaken internationally. Results of small trials have indicated that early interventions for social communication may be effective for the treatment of autism in children. In PACT, the authors aimed to provide a stringent test of a parent-child communication-focused intervention in children aged 2 years to 4 years and 11 months with diagnosed autism.

The rationale behind the PACT intervention was that these children would respond with enhanced communicative and social development if parents were able to adapt their communication to their child’s specific impairments. The intervention consisted of one-to-one clinic sessions with therapist and parents and children. The aim of the intervention was firstly to increase parental sensitivity and responsiveness to the autistic child’s particular pattern of communication using direct work with parents and video feedback methods. Then, the further incremental development of the child’s communication was encouraged by introducing a range of strategies such as action routines, matching language to the child’s understanding, and the use of pauses. After an initial orientation meeting, families attended fortnightly 2 hour clinic sessions for 6 months followed by monthly booster sessions for 6 months (maximum 18). Between sessions, families were also asked to do 30 minutes of daily home practice.

The study assessed 152 children, aged 2 years to 4 years and 11 months, across three UK sites. 77 children were assigned to the PACT intervention plus treatment as usual and 75 to just treatment as usual. Treatment as usual consisted of various generic and specialist autism services provided by local health, education and social care services.

Severity and improvement in autism symptoms were assessed using a modification of the Autism Diagnostic Observation Schedule-Generic [ADOS-G] total social communication score. At the 13-month endpoint, the severity of symptoms was reduced by 3•9 points in the group assigned to PACT and treatment as usual, and 2•9 in the group assigned to only treatment as usual. This represented a small between-group effect size in favour of PACT, after adjustment for centre, sex, socioeconomic status, age, and verbal and non-verbal abilities—a difference the authors deemed not significant in terms of clinical effect. However, the PACT intervention did lead to improvements in the timing of parents’ communicative interactions with their child and the amount that children communicated using speech and gestures when playing with their parents. Parents also reported improvements in their child’s language abilities.

The authors conclude: “On the basis of our findings, we cannot recommend the addition of this PACT intervention to treatment as usual for the purpose of reduction in autism symptoms. The intervention does, however, significantly alter parent-child dyadic social communication in ways that are associated with subsequent positive child outcomes in longitudinal studies, and are likely to be positive for parents themselves. Techniques to aid transmission of these gains in parent-child interaction to children's communication skills in wider contexts need to be assessed.”

The authors add that this study adds to the positive evidence-base for preschool interventions for children with autism that focus on improving children’s social interaction and communication, and that also offer support to parents following a diagnosis. However, in line with other recent studies these improvements did not lead to a reduction in the severity of autism symptoms. This difficulty in generalisation is a challenge for clinicians and researchers in trying to improve interventions for this disorder.

In an accompanying Comment, Dr Sarah J Spence, and Dr Audrey Thurm, Pediatrics and Behavioral Neuroscience Branch, Intramural Research Program of the National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA, say: “This study furthers the field by setting a new bar for the minimum standards of rigorous methodology needed in trials that have potentially far-reaching service and policy implications... At the same time, today’s study exemplifies the complexity of attempting to detect change in samples of young children with such a heterogeneous condition. There are very few positive published trials in autism, for behavioural interventions, traditional pharmacotherapy, or complementary/alternative therapies. Is this due to non-efficacious treatments, lack of sensitive outcome measures, or heterogeneity of autism—or perhaps all three?”

They conclude: “In addition to those [variables] examined within this study (eg, variability in diagnoses, baseline language and cognitive levels, socioeconomic status, and parent’s education, age, and sex), there remains a long list of issues that are difficult to even measure and certainly to account for in any sample of individuals with autism. These factors include environmental context, other treatments, co-morbid conditions, and as yet unknown differences in genetics and neuropathophysiology. Ultimately, the challenge is to define subtypes within this disorder. These definitions might have not only important treatment implications, but also aid in understanding aetiology.”

Questions and Answers Regarding the Study1. What was the main finding of the study?
We found that the 12 month parent training programme improved the timing of parents’ communicative interactions with their child and the amount that children with autism communicated using speech and gestures when playing with their parents. Parents also reported improvements in their children’s social communication and language ability. However against the predicted effect that improved parent-child interaction would positively impact on autism symptoms, the study found that there was no significant additional reduction in severity of autism in the treated group over and above that made by children receiving local services.

2. Was the trial successful?
The trial was very successful in terms of recruiting and retaining families and implementing and maintaining a high level of methodological rigour. The parent training approach was also successful in its aims to change the way that parents interacted with their child and it seems that this led over time to changes in the children’s communication, such as using more speech and gestures, when they were interacting with them. However, we had predicted that this might lead to a reduction in autism symptoms but on the measure we used (Autism Diagnostic Observation Schedule; ADOS) there we no differences over time in the amount in which scores changed compared to the families who received local services only. More work is required to help us understand how to generalise the improvements we saw in parent child communication to communicating and interacting with others. It remains unclear whether this will lead over a short period of time to a reduction in autism symptoms, especially in the preschoolers with ‘core’ autism who were included in our study.

3. Would you recommend this treatment to families? Should this treatment be made available through the NHS? What about the NAS EarlyBird scheme?
Treatments such as the PACT intervention and other developmental approaches that also emphasise promoting early social and communication skills are some of the best evidence-based approaches for preschool children with autism. Other approaches, including behaviour approaches, have also shown positive outcomes in well controlled research studies – although it is only recently that a significant number of ‘gold standard’ randomised controlled trials have gotten underway. One advantage to parent training approaches is that parents find them supportive and enabling, especially when delivered in the period following on from diagnosis, and this was the experience of parents in our study. Preschool children with core autism present with complex and multiple needs and social communication focused early intervention approaches should usually be only one element (although a core one) of any comprehensive programme offered to families.

On the basis of the findings of our study we would not recommend the particular configuration of parent training that we delivered in the PACT trial for all preschool children with autism via the NHS. The trial provides sound evidence that this type of intervention can bring about changes in parents behaviour and improvements in their children’s communication. Parent training is one of approaches commonly adopted by speech and language therapists who work with preschool children with autism. We hope that the results of the trial will encourage dissemination of the findings and training in such methods for healthcare and early education professionals as they are one of the approaches with the strongest evidence-base.

The PACT approach draws on some of the same approaches as the NAS EarlyBird scheme. However, it also differs in aspects of delivery (EarlyBird involves group sessions; PACT only involved individual work with parents) and content (EarlyBird involves formal psychoeducational information about autism; PACT focuses on parents’ reciprocal social interaction with their child). Like EarlyBird most parents found PACT to be a positive and supportive intervention that was empowering in the months following diagnosis. EarlyBird is a promising approach but has not been robustly evaluated in terms of its effectiveness in the way that we have tested the PACT intervention.

4. How is your treatment different to other treatments?
The PACT intervention shares elements in common with other approaches that focus on emerging social communication skills and that follow developmental principles and place an emphasis on reciprocal social relating (AKA social interaction) – in our case between parents and children. The particular techniques and exercises that different programmes adopt differ but also commonly have many areas of overlap. Our parent training intervention was not an intensive approach, with therapists having fortnightly sessions with parents for 6 months and then monthly booster sessions for a further 6 months. Families continued throughout the period to continue to receive other local services and by the end of the trial most children were in nursery or preschool.

5. How does your finding compare to that of other recent treatment studies? For example the ESDM study published in January?
Our study is one of the few randomised controlled trials that have been conducted of psychosocial interventions for preschoolers with autism in the past few years and by some considerable way the largest. Other studies, including our own pilot trials, have also suggested positive benefits in social and communication outcomes for such approaches. There is pretty consistent evidence that developmental approaches, that build on the good evidence we have for how communication emerges from social interactions between typically developing infants and their caregivers, can promote positive changes in early communication and social interactions in preschool children with autism. This can be via parent training (PACT) or by direct work with therapists (Kasari) or a combination of both (ESDM). Our findings are line with several of these other studies in demonstrating that some aspects of social interaction and communication are improved but also that it is harder to reduce the severity of autism symptoms. Further trials are required to test whether such a goal is achievable – notwithstanding the fact that the improvements we have found are meaningful for parents and for children.

The ESDM trial reported early this year by Drs. Dawson and Rogers and colleagues is a very different kind of treatment in some ways – therapists worked relatively intensively with children (15 hours per week for 2 years, alongside a similar amount of parent work with their children) and the intervention specifically employed behavioural techniques which we did not in our therapy. In other ways there are similarities – particularly in the adoption of a developmental approach and the emphasis on reciprocal social interaction and social relating. Both studies showed improvements in some aspects of communication but neither found a reduction in ADOS scores.

6. Was the treatment successful for all children? Who benefited most from the treatment? Why?
We have only begun to explore this question so cannot give a full answer. In the analysis of our main (primary) outcome of autism severity (ADOS) we did not find a main treatment effect; neither did we find a significant effect for subgroups based on non-verbal ability, language ability, initial severity, age or family background. We will be looking at whether these factors are associated with differences on the secondary outcomes that we have reported today including parent-child communication. In our experience treatment response is very variable in every trial that has been conducted, with some children in both the treatment and the control groups making great progress, others in both groups less progress and still others little progress at all. We will use the rich data from our study – one of the few large enough to test out these issues (what we call ‘differential treatment response’) – so that we can develop and test new approaches to supporting those children whose respond less well to treatment in future studies.

In the PACT study we deliberately chose to focus on 2 to 4 year olds with ‘core’ autism, many of whom also had intellectual disability and challenging behaviour. We do not know how PACT would work with children with less severe presentations (sometimes called ‘broader autism spectrum disorder’) – and that might be something important to test in future.

7. What are the next studies your group is going do? Are you going to see the families again?
First of all, we’d like to see the same families again to see what the longer term effects of the changes we saw over a period of 12 months might be. The children are now mostly in school so it would be important to see whether time-limited preschool intervention has any lasting impact. This will be something we will be applying for a new grant to do over the next year.

Yes, we’d also like to do some future studies that help us understand better what aspects of the treatment approach were successful or most important in bringing about change in parents’ and children’s behaviour, as well as the factors that limit generalisation to other contexts or interaction with other people. We’d also like to see whether shorter treatments can also make a difference as this would have implications for how widely they can be made available on the NHS.

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